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This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to collect detailed information to help your physician and other researchers understand how dystonia impacts your and other patients' lives and how the disease changes over time. The study may also help researchers better understand the clinical scales that are commonly used to evaluate dystonia symptoms and how they affect various areas of life such as well-being, pain, relationships and social interactions, and progress over time. Because this is an observational study, you will not receive any interventional treatment in the study.
The primary goal of this observational study is to further characterize and quantify disease severity and impact (including change over time) in individuals with either segmental, multifocal, or generalized dystonia in a structured manner, utilizing and comparing various well-known scales. In addition, medication history and any intercurrent events related to the participant's health (such as, but not limited to, hospitalizations, new diagnoses, etc.) will be captured. This study will provide standardized data to support planned future interventional clinical studies in this patient population and will provide a greater understanding of the population under study and the performance of clinical ratings scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated (or Primary) Dystonia Cohort | This is a single-arm noninterventional, prospective observational study enrolling up to 200 male and female participants (ages 12 - 65 years, inclusive) that have been diagnosed with isolated dystonia for at least one year prior to the first study visit. Candidates with focal dystonia (i.e., only one body part affected) are not eligible for participation. However, the Investigator may query such patients to determine if symptoms have spread to other regions, which may allow them to be eligible for study entry. |
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| Measure | Description | Time Frame |
|---|---|---|
| Burke-Fahn-Marsden (BFM) Dystonia Rating Scale | The BFM was developed to quantitatively assess primary dystonias (Burke 1985). It is composed of 2 subscales: a movement subscale, based on the clinician's evaluation of the patient in nine body areas, and a disability subscale, based on the participant's report of disability in activities of daily living. | From start of treatment through 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2) | The TWSTRS-2 scale is used to assess cervical dystonia. It includes 3 subscales that evaluate symptom severity, disability, and pain. The severity scale is clinician-rated and the disability scale is patient-rated based on 6 items related to work, activities of daily living, driving, reading, watching TV, and outside activities. | From start of treatment through 4 months |
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Inclusion Criteria: Each participant must meet the following criteria at Visit 1 to be eligible to continue in the study:
Exclusion Criteria: Any participant who meets any of the following criteria at Visit 1 will be excluded from this study:
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Isolated (Primary) Dystonia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 617-430-7027 | clinicaltrials@vimatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vima Site #004 | Recruiting | Scottsdale | Arizona | 85258 | United States |
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| Clinical Global Impression of Severity (CGI-S) | The CGI-S score is used by the Investigator to determine, in a global sense, how severe the patients' blepharospasm is in the context of other blepharospasm patients. Increased scores indicate more severe symptoms. | From start of treatment through 4 months |
| Vima Site #028 | Recruiting | Sun City | Arizona | 85351 | United States |
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| Vima Site #010 | Recruiting | Aliso Viejo | California | 92656 | United States |
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| Vima Site #030 | Recruiting | Los Angeles | California | 97239 | United States |
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| Vima Site #022 | Recruiting | Palo Alto | California | 94301 | United States |
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| Vima Site #019 | Recruiting | Englewood | Colorado | 80113 | United States |
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| Vima Site #003 | Recruiting | Boca Raton | Florida | 33486 | United States |
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| Vima Site #009 | Recruiting | Gainesville | Florida | 32611 | United States |
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| Vima Site #008 | Recruiting | Miami | Florida | 33176 | United States |
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| Vima Site #031 | Recruiting | Orlando | Florida | 32825 | United States |
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| Vima Site #005 | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Vima Site #027 | Recruiting | Chicago | Illinois | 60611 | United States |
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| Vima Site #007 | Recruiting | Olney | Maryland | 20832 | United States |
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| Vima Site #002 | Recruiting | Farmington Hills | Michigan | 48334 | United States |
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| Vima Site #014 | Recruiting | Albuquerque | New Mexico | 87106 | United States |
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| Vima Site #017 | Recruiting | Commack | New York | 11725 | United States |
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| Vima Site #018 | Recruiting | New York | New York | 10029 | United States |
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| Vima Site #024 | Recruiting | New York | New York | 10065 | United States |
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| Vima Site #029 | Recruiting | Portland | Oregon | 97239 | United States |
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| Vima Site #020 | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Vima Site #021 | Recruiting | Charleston | South Carolina | 29407 | United States |
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| Vima Site #016 | Recruiting | Memphis | Tennessee | 38157 | United States |
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| Vima Site #006 | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Vima Site #025 | Recruiting | Dallas | Texas | 75390 | United States |
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| Vima Site #026 | Recruiting | Georgetown | Texas | 78628 | United States |
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| Vima Site #012 | Not yet recruiting | Houston | Texas | 77030 | United States |
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| Vima Site #011 | Recruiting | Richmond | Virginia | 23298 | United States |
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| Vima Site #023 | Recruiting | Kirkland | Washington | 98034 | United States |
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| Vima Site #015 | Recruiting | Spokane | Washington | 99202 | United States |
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| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020821 | Dystonic Disorders |
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
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